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Photodynamic Therapy in Non-surgical Periodontal Therapy

Microbiological and Clinical Efficacy of Photodynamic Therapy in Combination With Non-surgical Periodontal Therapy: a Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07080762
Acronym
aPDT-PD
Enrollment
50
Registered
2025-07-23
Start date
2024-01-08
Completion date
2024-11-30
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Photodynamic Therapy, Periodontitis, Photodynamic Therapy (PDT)

Keywords

Photodynamic Therapy, periodontitis

Brief summary

Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. This method aims to disrupt the pathogenic bacterial load within periodontal pockets and promote clinical attachment gain while reducing inflammation. However, the mechanical removal of biofilm alone may not always ensure complete bacterial eradication, especially in deep or anatomically complex sites. To enhance bacterial disinfection and optimize clinical outcomes, adjunctive use of antimicrobial photodynamic therapy (aPDT) has been introduced. aPDT is a non-invasive technique that involves the activation of a photosensitizing agent by light at a specific wavelength, leading to the production of reactive oxygen species capable of selectively damaging microbial cells. This reaction occurs without affecting surrounding healthy tissues and has been shown to be effective against a broad spectrum of periodontal pathogens. The synergistic effect of combining conventional non-surgical periodontal therapy with aPDT allows for a more comprehensive decontamination of periodontal pockets. In particular, aPDT contributes to the disruption of residual bacterial biofilm that may persist after mechanical instrumentation, thereby potentially improving both short- and long-term periodontal stability. In addition to its antimicrobial action, aPDT may exert a biostimulatory effect, enhancing tissue healing through increased local microcirculation and cellular activity. This study aims to evaluate the clinical efficacy of adjunctive antimicrobial photodynamic therapy following non-surgical periodontal treatment in patients with severe periodontitis. The protocol involves initial subgingival instrumentation using ultrasonic and manual tools, followed by the application of a photosensitizer and subsequent laser activation within the periodontal pockets. The hypothesis of this study is that the addition of aPDT provides superior bacterial reduction and improved clinical outcomes compared to mechanical therapy alone.

Interventions

DEVICEantimicrobial photodynamic therapy (aPDT) after non-surgical therapy

In the test, a photoactive substance activated with laser light (20 mW, 660 nm) was applied to the post-non-surgical site for 60 seconds to promote disinfection Other Name: antimicrobial photodynamic therapy (aPDT) after non surgical therapy

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes

Inclusion criteria

* Age between 18 and 84 years; * Good general health status; * Diagnosis of severe periodontitis involving at least 30% of all teeth, with at least three non-adjacent teeth presenting three sites with probing pocket depth (PPD) greater than 4 mm in at least two quadrants, and having lost at least four teeth due to periodontitis; * Presence of at least 16 teeth, with a minimum of four teeth per quadrant.

Exclusion criteria

* Pregnancy or breastfeeding; * Presence of decompensated systemic diseases that may compromise the outcomes of the study or the patient's health; * Regular use of antibiotics; * Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids, or aspirin); * Use of anticoagulant medications; * History of systemic antibiotic therapy within six months prior to enrollment; * History of any periodontal therapy within six months prior to enrollment; * Presence of severe mental or cognitive disorders.

Design outcomes

Primary

MeasureTime frameDescription
Probing Pocket Depth PPD IndexT0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)Probing depth is the distance from the gingival margin to the base of the pocket (mm)
Microbiological analysisT0 (Baseline), T2 (14 days after baseline), T3 (3 months after baseline)The microbiological analysis qualitatively (yes/no) assesses the presence of six types of periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Treponema denticola, Actinomyces naeslundii) using sterile paper points inserted into the periodontal pocket prior to non-surgical periodontal therapy. For each site analyzed, two saliva samples are collected: one is placed in a test tube containing ethanol, and the other in a tube containing ammonium thioglycolate. The samples are subsequently transported to the microbiology department of the Integrated University Hospital of Verona for analysis.

Secondary

MeasureTime frameDescription
Recession REC IndexT0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)Recession is the apical shift of the marginal tissues associated with the attachment loss exposing the root or implant surface to the oral environment (mm)
Clinical attachment level CAL IndexT0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)measured in mm as distance from the CEJ to the gingival margin (GM)
Plaque IndexT0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)This index ascertains the thickness of plaque along the gingival margin (%)
Bleeding on probing BOP IndexT0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)is an indicator of tissue inflammatory response to bacterial pathogens (%)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026